FLUDARA Powder for solution for injection or infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Fludara 50 mg powder for solution for injection or infusion.
Qualitative and quantitative composition
Each vial contains 50 mg fludarabine phosphate. One ml of reconstituted solution contains 25 mg fludarabine phosphate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for injection or infusion. White lyophilisate for reconstitution.
Therapeutic indications
Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult patients with sufficient bone marrow reserves. First line treatment with Fludara should only be initiated in adult patients with advanced ...
Posology and method of administration
Posology The recommended dose is 25 mg fludarabine phosphate/m² body surface area given daily for 5 consecutive days every 28 days by intravenous route. Each vial is to be made up in 2 ml water for injection. ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Renal impairment with creatinine clearance <30 ml/min. Decompensated haemolytic anaemia. Lactation.
Special warnings and precautions for use
Myelosuppression Severe bone marrow suppression, notably anaemia, thrombocytopenia and neutropenia, has been reported in patients treated with Fludara. In a Phase I intravenous study in adult solid tumour ...
Interaction with other medicinal products and other forms of interaction
In a clinical investigation using intravenous Fludara in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukaemia (CLL), there was an unacceptably high ...
Fertility, pregnancy and lactation
Fertility Women of childbearing potential must be apprised of the potential hazard to the foetus. Both sexually active men and women of childbearing potential must take effective contraceptive measures ...
Effects on ability to drive and use machines
Fludara may reduce the ability to drive and use machines, since e.g. fatigue, weakness, visual disturbances, confusion, agitation and seizures have been observed.
Undesirable effects
Summary of safety profile Based on the experience with the use of Fludara, the most common adverse events include myelosuppression (neutropenia, thrombocytopenia and anaemia), infection including pneumonia, ...
Overdose
High doses of Fludara have been associated with leukoencephalopathy, acute toxic leukoencephalopathy, or reversible posterior leukoencephalopathy syndrome (RPLS). Symptoms may include headache, nausea ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, purine analogues ATC-code: L01BB05 Mechanism of action Fludara contains fludarabine phosphate, a water-soluble fluorinated nucleotide analogue of the antiviral ...
Pharmacokinetic properties
Plasma and urinary pharmacokinetics of fludarabine (2F-ara-A) The pharmacokinetics of fludarabine (2F-ara-A) have been studied after intravenous administration by rapid bolus injection and short-term infusion ...
Preclinical safety data
Systemic toxicity In acute toxicity studies, single doses of fludarabine phosphate produced severe intoxication symptoms or death at dosages about two orders of magnitude above the therapeutic dose. As ...
List of excipients
Mannitol Sodium hydroxide (to adjust the pH to 7.7)
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Unopened vial: 3 years. Reconstituted and diluted solution: Chemical and physical in-use stability after reconstitution has been demonstrated for 7 days at 4°C. From a microbiological point of view, the ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions of the reconstituted or diluted medicinal product, see section 6.3.
Nature and contents of container
10 ml colourless Type I glass vials containing 50 mg fludarabine phosphate. Pack size: 5 vials per carton.
Special precautions for disposal and other handling
Reconstitution Fludara should be prepared for parenteral use by aseptically adding sterile water for injection. When reconstituted with 2 ml of sterile water for injection, the powder should fully dissolve ...
Marketing authorization holder
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Marketing authorization number(s)
PL 12375/0039
Date of first authorization / renewal of the authorization
Date of first authorisation: 11 August 1994 Date of last renewal: 07 August 2009
Date of revision of the text
10 March 2019
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